Cleared Traditional

K943806 - HARPOON SUTURE ANCHORS

K943806 is an FDA 510(k) clearance for HARPOON SUTURE ANCHORS, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K943806 · Biomet, Inc. · Orthopedic device
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Jul 1995
Decision
333d
Days
Class 2
Risk

K943806 is an FDA 510(k) clearance for the HARPOON SUTURE ANCHORS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 3, 1995 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet, Inc. devices

FDA 510(k) Submission Details - K943806

510(k) Number K943806 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 04, 1994
Decision Date July 03, 1995
Days to Decision 333 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 122d · This submission: 333d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K943806.
ABSORBABLE ACETABULAR SCREW
K946347 · Zimmer, Inc. · Jul 1995
DEPUY SET SCREW
K950833 · Depuy, Inc. · Jul 1995
ORTHOPEDIC SCREW FIXATION
K932350 · Osteomed Corp. · Jul 1995
OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS
K950652 · Osteotech, Inc. · Jun 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
K951304 · Synthes (Usa) · Jun 1995
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
K934590 · Smith & Nephew Richards, Inc. · Jun 1995